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Data / Medical devices / Argentina / Wiener Laboratorios S.A.I.C.

Wiener Laboratorios S.A.I.C.: FDA-registered device maker in ROSARIO Santa Fe, Argentina, 26 510(k) clearances

Wiener Laboratorios S.A.I.C. is registered with the FDA (registration 8040374) in ROSARIO Santa Fe, Argentina. It lists 50 device types. The FDA files 26 510(k) clearances under its listings, the newest dated September 2, 2009. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
8040374
FEI number
5864
Address
2571 Maipu, ROSARIO Santa Fe, Argentina, 2000
Owner or operator
WIENER LABORATORIOS S.A.I.C. (8040374)
Roles
Manufacturer
First device listed
June 14, 1985
Registered through
2026
Brand names listed
2,4-DINITROPHENYLHYDRAZINE, LACTATE DEHYDROGENASE, ACID, FERRIC ION-SULFURIC, CHOLESTEROL, ALP 405 Cinetica Optimizada, ALP 405 AA Liquida, APOLIPOPROTEINS, ASO latex Directo Maxi, ASO Latex Turbitest AA, Albumin Turbitest AA, Albumina AA, Amilasa 405 Cinetica AA, Amilasa 405 Cinetica Unitest, Amilasa 405 AA Liquida and more

Devices it lists

DeviceProduct codeClassRoleSource
2,4-Dinitrophenylhydrazine, Lactate DehydrogenaseCER2Manufactureraccessdata.fda.gov
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)JMA1Manufactureraccessdata.fda.gov
Acid, Ferric Ion-Sulfuric, CholesterolCHD1Manufactureraccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Manufactureraccessdata.fda.gov
Albumin, Antigen, Antiserum, ControlDCF2Manufactureraccessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O ReagentGTQ1Manufactureraccessdata.fda.gov
ApolipoproteinsMSJ1Manufactureraccessdata.fda.gov
Azo Dye, CalciumCJY2Manufactureraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Manufactureraccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Manufactureraccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Manufactureraccessdata.fda.gov
Bromcresol Green Dye-Binding, AlbuminCIX2Manufactureraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Manufactureraccessdata.fda.gov
Catalytic Methods, AmylaseJFJ2Manufactureraccessdata.fda.gov
Colorimetric Method, TriglyceridesJGY1Manufactureraccessdata.fda.gov
Colorimetry, CholinesteraseDIH1Manufactureraccessdata.fda.gov
Cresolphthalein Complexone, CalciumCIC2Manufactureraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Manufactureraccessdata.fda.gov
Diazo Colorimetry, BilirubinCIG2Manufactureraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Manufactureraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Manufactureraccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Manufactureraccessdata.fda.gov
Enzymatic Method, CreatinineJFY2Manufactureraccessdata.fda.gov
Enzyme Linked Immunosorbent Assay, T. CruziMIU1Manufactureraccessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding CapacityJMO1Manufactureraccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Manufactureraccessdata.fda.gov
Hydrazone Colorimetry, Alt/SgptCKD1Manufactureraccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Manufactureraccessdata.fda.gov
Kinetic Method, Gamma-Glutamyl TranspeptidaseJQB1Manufactureraccessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlLBS1Manufactureraccessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, LipaseCHI1Manufactureraccessdata.fda.gov
Lowry (Colorimetric), Total ProteinJGP2Manufactureraccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Manufactureraccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Manufactureraccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or IsoenzymesCGS2Manufactureraccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate DehydrogenaseCFJ2Manufactureraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/SgptCKA1Manufactureraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/SgotCIT2Manufactureraccessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesCJE2Manufactureraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Manufactureraccessdata.fda.gov
Olive Oil Emulsion (Turbidimetric), LipaseCET1Manufactureraccessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic PhosphorusCEO1Manufactureraccessdata.fda.gov
Photometric Method, Iron (Non-Heme)JIY1Manufactureraccessdata.fda.gov
Photometric Method, MagnesiumJGJ1Manufactureraccessdata.fda.gov
Prealbumin, Antigen, Antiserum, ControlJZJ1Manufactureraccessdata.fda.gov
Refractometer For Clinical UseJRE1Manufactureraccessdata.fda.gov
Test, Urine LeukocyteLJX1Manufactureraccessdata.fda.gov
Turbidimetric Method, LipoproteinsJHN1Manufactureraccessdata.fda.gov
U.V. Method, Cpk IsoenzymesJHW2Manufactureraccessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea NitrogenCDQ2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 2, 2009K083724WIENER LAB. URINE STRIP 10 AND 11JIOSubstantially EquivalentWiener Laboratorios Saicaccessdata.fda.gov
February 11, 2004K023889WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254MIUSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
March 19, 2003K030482WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553JJYSubstantially EquivalentWiener Laboratoriesaccessdata.fda.gov
March 18, 2003K024305WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006JIXSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
February 12, 2003K024116WIENER LAB. BILIRUBINA DIRECT AACIGSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
February 12, 2003K023992WIENER LAB COLINESTERASA AADIHSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
January 3, 2003K023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354JHWSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
December 9, 2002K023551WIENER LAB GOT (AST) UV AA LIQUIDACITSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
December 9, 2002K023550WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDAKNKSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
December 9, 2002K023549WIENER LAB AMILASA 405 AA LIQUIDAJFJSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
November 1, 2002K022962WIENER LAB. BILIRRUBINA TOTAL AACIGSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
September 10, 2002K021334WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5CJYSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
July 3, 2002K021332WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDACGSSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
January 28, 2002K013983WIENER LAB. ALP 405CJESubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
December 21, 2001K013652WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002CICSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
December 21, 2001K011953WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCACGASubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
November 27, 2001K013145WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.CITSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
November 16, 2001K013101WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AAJFJSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
November 16, 2001K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311CEOSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
November 13, 2001K013102WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002JMOSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
November 13, 2001K013097WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003JIYSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
November 8, 2001K012326WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001JGJSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
October 10, 2001K012065WIENER LAB. CREATININA CINETICA AAJFYSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
September 21, 2001K012329WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300CIXSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
September 19, 2001K012260WIENER LAB. UREA UV CINETICA AACDQSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov
April 13, 2001K010421WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105KNKSubstantially EquivalentWiener Laboratories Saicaccessdata.fda.gov

Compare with other makers

Updated September 2, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.